topcare acid reducer (36800-141)

Drug Facts

Product Profile

Brand Name topcare acid reducer

Generic Name famotidine

Labeler topco associates llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

famotidine 10 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-141

Product ID 36800-141_c15b21b3-6e50-4ed4-90ef-28483e1cf535

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA075400

Listing Expiration 2026-12-31

Marketing Start 2009-09-11

Pharmacologic Class

Established (EPC)

histamine-2 receptor antagonist [epc]

Mechanism of Action

histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800141

Hyphenated Format 36800-141

Supplemental Identifiers

RxCUI

199047

UNII

5QZO15J2Z8

NUI

N0000000151 N0000175784

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topcare acid reducer (source: ndc)

Generic Name famotidine (source: ndc)

Application Number ANDA075400 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

30 BLISTER PACK in 1 CARTON (36800-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK
1 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (36800-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (3)

36800-141-65 30 BLISTER PACK in 1 CARTON (36800-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK 36800-141-72 1 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE 36800-141-75 1 BOTTLE in 1 CARTON (36800-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

famotidine (10 mg/1)

Linked Drug Pages (1)

TopCare Acid Reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c15b21b3-6e50-4ed4-90ef-28483e1cf535", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047"], "spl_set_id": ["88722f84-dac8-4130-93b3-9e0dc1cc5acc"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (36800-141-65)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "36800-141-65", "marketing_start_date": "20091013"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-141-72)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-141-72", "marketing_start_date": "20090911"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-141-75)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-141-75", "marketing_start_date": "20210322"}], "brand_name": "TopCare Acid Reducer", "product_id": "36800-141_c15b21b3-6e50-4ed4-90ef-28483e1cf535", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "36800-141", "generic_name": "Famotidine", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Acid Reducer", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA075400", "marketing_category": "ANDA", "marketing_start_date": "20090911", "listing_expiration_date": "20261231"}